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Reference Number:
MS_CCS-EHNJ
Job Description:
Our client is a major pharameutical company and they are looking for a Clinical Coding Specialist for a 6+ month position in East Hanover, NJ.
Position Description
Ensure consistency of coding across and within projects with particular emphasis on adverse events .
Contribute to and review Validation and Planning (eVAP) coding section.
Input into User Acceptance Testing (UAT) specifically for coded term fields.
Consult with International Clinical Team Leaders, Medical Advisors, CDMs, CDAs, ICRO Field Monitors, Investigators and Statisticians to resolve coding problems and queries.
Manually encode medical and therapy terms not automatically encoded by the data management system.
Generate requests for new Medical and Therapy terms and changes to existing terms, and ensure appropriate changes are made to the dictionaries as agreed.
Develop and maintain excellent knowledge of medical and therapy terms using appropriate information tools, e.g. electronic dictionaries, internet etc.
Provide assistance if required for Contract Research Organisations (CROs).
Provide medical terminology glossaries for review by project CPEs for Clinical Pharmacology trials.
Participate in initiatives to improve the coding processes and systems.
Requirements:
Degree in life sciences, pharmacy, nursing (e.g. SRN in UK) or equivalent relevant experience.
Typically 2 or more years experience in drug development, including 1 or more years in the discipline of data managemen. Understanding of clinical trial methodology, GCP and medical terminology. Understanding of dictionary philosophy specifically with regard to MedDRA and WHODRL.
Good computer skills
Attention to detail
Good organisational and planning skills
Good interpersonal and communication skills and the ability to operate effectively in an international envi-ronment
Good understanding of physiology, pharmacology, clini-cal study objectives and the drug development process.
Good problem solving skills.
Ability to work as part of a team and without close su-pervision.
Ability to work under pressure and meet timelines
Qualified candidates should please send a MS Word copy of their resume to manisha@sunrisesys.com. PLEASE INCLUDE THE JOB REF # "CCS-EHNJ" IN THE SUBJECT LINE!
Experience Level:
Unspecified
Requirements:
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